These products contained an undeclared drug ingredient, sildenafil, which is the active ingredient in FDA-approved prescription drugs used to treat erectile dysfunction. The labels of the products Elgayar sold failed to include the name and quantity of the drug ingredient, according to the information.

Undeclared drugs such as sildenafil may have serious potential side effects or may be harmful to consumers with certain pathological conditions. Additionally, undeclared drugs may interact dangerously with other prescription or non-prescription drugs the unwitting consumer might be taking. The labels for the products the defendant provided failed to adequately warn consumers of these contingencies, according to the information.

Elgayar received misbranded drugs and delivered or proffered delivery of those misbranded drugs between January and October 2016, according to the information.

“Disguising prescription drugs as harmless over-the-counter products can lead to serious consequences for unsuspecting buyers with dangerous underlying health conditions. It could also lead to dangerous interactions when combined with other drugs they may be taking,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations, Metro Washington Field Office. “Our office will continue to pursue and bring to justice those who would endanger the public’s health in order to make a quick profit.”

If convicted, the court will determine defendant’s sentence after review of factors unique to this case, including the defendant’s prior criminal record, if any, the defendant’s role in the offense, and the characteristics of the violations. In all cases, the sentence will not exceed the statutory maximum and, in most cases, it will be less than the maximum.

The matter is being prosecuted by Assistant U.S. Attorneys Megan R. Miller and Michael L. Collyer following an investigation by the Food and Drug Administration.

An information is only a charge and is not evidence of guilt. A defendant is entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.